Opatanol 1mg/ml eye drops solution

  • Name:

    Opatanol 1mg/ml eye drops solution

  • Company:
    info
  • Active Ingredients:

    Olopatadine (as hydrochloride)

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/04/19

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Summary of Product Characteristics last updated on medicines.ie: 8/4/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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1 - 0 of 116 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 10 April 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 8 April 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 25 March 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 25 May 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 7 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 7 June 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

- Update to SPC following approval of transfer of MAH from Alcon to Novartis.

Updated on 6 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 June 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 15 April 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

- Update to ADR reporting information.

Updated on 13 April 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 3 February 2014 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 January 2014 PIL

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 11 November 2013 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Section 1: Minor amendment to text "ml" to "mL"
  • Section 2: Minor amendment to text "ml" to "mL" and addition of "with known side effects"
  • Section 4.2: Revisied method of and added additional use in peadriatric population
  • Section 4.3: Minor amendment to text added "listed in section 6.1."
  • Section 4.4: Revised information on Benzalkonium chloride
  • Section 4.5: Minor amendment to text added "with other medicinal products"
  • Section 4.6: Revised existing pregnancy and lactation information with new info. Added Fertility information
  • Section 4.7: Added "Opatanol has no or negligible influence on the ability to drive and use machines."
  • Section 4.8: "Undesirable effects" changed to "adverse reactions" throughout. Adverse reactions converted into tabulated format. Added "Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas." Added national information on Reporting of suspected adverse reactions
  • Section 5.2: Added headiungs "Absorption" and "Elimination"
  • Section 5.3: Added "Studies in animals have shown reduced growth of nursing pups of dams receiving systemic doses of olopatadine well in excess of the maximum level recommended for human ocular use. Olopatadine has been detected in the milk of nursing rats following oral administration."
  • Section 6.2: Added "In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products."
  • Section 6.3: Added heading "Shelf-life after first opening"
  • Section 9: Minor amendment to text "last" to "latest"
  • Section 10: Updated revision date

Updated on 8 November 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to appearance of the medicine

Updated on 14 August 2013 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 16 July 2013 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 31 May 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

MAH address update

Updated on 29 May 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 29 November 2011 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 7 June 2011 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Date of revision of the text has been included. This was missing from previous version of the SPC.

Updated on 19 January 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 - Whole section amended

Section 3 - Whole section amended

Section 4.2 - 'Use in children and adolescents' paragraph removed, replaced with 'Paediatric patients'

Section 4.3 - Whole section amended

Section 4.5 - 'No clinical interaction studies were performed with Opatanol' has been changed to 'No interaction studies have been performed'

Section 4.8 - Whole section amended

Section 5.3 - The word 'preclinical' has been changed to 'Non-clinical'

Section 6.2 - 'None known' has been changed to 'Not applicable'

Section 6.4 - Whole section amended

Section 6.5 - Whole section amended

Section 9 - Date of last renewal added

Section 10 - Date added

Updated on 13 August 2007 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 
   4.3 Updates to section

Updated on 13 August 2007 PIL

Reasons for updating

  • Change of contraindications

Updated on 18 May 2005 PIL

Reasons for updating

  • Change to further information section

Updated on 29 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 12 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)